Reproductive Function and Mood in Women With Bipolar Disorder

NCT ID: NCT00183352

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-07-31

Brief Summary

This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.

Detailed Description

Bipolar disorder is a serious condition that can have devastating effects on social and psychological functioning. Evidence suggests that medications for bipolar disorder may influence reproduction function among women. This study will determine reproductive function and mood changes in women who are currently on medication for bipolar disorder.

This study will comprise women with bipolar disorder and age- and body mass index (BMI)-matched healthy controls. Participants will have their reproductive function and mood changes assessed for 3 consecutive menstrual cycles. Daily, participants will report about their mood, sleep patterns, life events, and any psychiatric medications; this information will be entered into a computerized system named ChronoRecord. In addition, participants will measure their basal body temperature and collect their urine every morning to assess for ovulation. Blood collection will occur at study entry and between Days 3 and 6 of every menstrual cycle to determine levels of reproductive hormones. Participants will be asked to fast for 12 hours prior to every blood collection. During the first month of the study, an extra study visit will occur. Participants will undergo a physical exam for determination of excessive hair growth (hirsutism) and BMI. Additionally, insulin resistance will be measured, and participants will be asked to complete a questionnaire that will be used to determine their past and current menstrual function, as well as the reproductive and psychiatric history of their families.

Conditions

Bipolar Disorder; Mental Health

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Women with bipolar disorder

No interventions assigned to this group

2

Women who are healthy controls

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Have been menstruating for at least 4 years prior to study entry
• Participants must be willing to travel to Stanford University at own expense for study visits

• Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS), and be under the treatment of a physician who can be contacted in case of an emergency
• Current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic)

• No past or present diagnosis of mental illness

Exclusion Criteria

• Current alcohol or substance abuse or dependence within 6 months prior to study entry
• Meets criteria for another DSM-IV Axis I disorder
• Contraceptive steroid use within 3 months prior to study entry
• Current use of medication that may affect steroid metabolism
• Menopausal
• Endocrine disease such as diabetes or hypothyroidism
• Uncontrolled medical illness
• History of long-term corticosteroid use
• Organic mood disorder
• Pregnancy or breastfeeding within 3 months prior to study entry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Natalie Rasgon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalie L. Rasgon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Behavioral Sciences, Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

R01MH066033

Identifier Type: NIH

Identifier Source: secondary_id

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SPO# 28571

Identifier Type: -

Identifier Source: secondary_id

DAHBR 96-BHC

Identifier Type: -

Identifier Source: secondary_id

R01MH066033

Identifier Type: NIH

Identifier Source: org_study_id

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